Transvenous Optoacoustic-Ultrasound Guided Cold Laser Wire for Crossing Coronary Chronic Total Occlusion

经静脉光声超声引导冷激光线穿越冠状动脉慢性完全闭塞

• 批准号: 10435198
• 负责人: MARC David FELDMAN
• 金额: $ 63.44万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10435198
• 关键词: Acute; Address; Adipose tissue; Affect; American; Angiography; Animal Model; Anterior Descending Coronary Artery; Arterial Fatty Streak; Arteries; Atherosclerosis; Blood flow; Bypass; Caliber; California; Cardiac; Cardiac Tamponade; Cardiology; Cardiovascular Diseases; Catheters; Cessation of life; Chest Pain; Chronic; Clinic; Complex; Complication; Coronary; Coronary Artery Bypass; Coronary artery; Development; Devices; Discipline; Disease; Dissection; Endothelial Cells; Environment; Event; Failure; Family suidae; Fatigue; Fiber; Frail Elderly; Goals; Health; Heart; Heart Transplantation; Hour; Human; Image; Injury; Institutes; Intervention; Lasers; Left; Left Ventricular Ejection Fraction; Length of Stay; Lesion; Light; Mechanics; Medical; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Optics; Organ Transplantation; Outcome; Participant; Patient-Focused Outcomes; Patients; Perforation; Peripheral; Procedures; Program Development; Recovery; Research; Shortness of Breath; Side; Stents; Structure of left gastric vein; Symptoms; System; Techniques; Testing; Therapeutic; Time; Treatment Protocols; Ultrasonography; Universities; Veins; base; calcification; cell injury; cost; design; image guided; imaging system; improved; in vivo; innovation; minimally invasive; mortality; novel; optical fiber; percutaneous coronary intervention; photoacoustic imaging; pressure; randomized controlled study; real-time images; reduce symptoms; research and development; restenosis; safe patient; sound; stent thrombosis; ultrasound

ABSTRACT Coronary chronic total occlusions (CTOs) are atherosclerotic plaques comprised of hard fibro-calcific material that restrict luminal cross-section by 100% resulting in complete stoppage of blood flow in the affected artery for at least three months. CTO symptoms include shortness of breath with chronic fatigue and chest pain. The three primary CTO treatment regimens are medical therapy (MT), coronary artery bypass graft (CABG) and percutaneous coronary interventions (PCI). MT can reduce symptoms such as chest pain but fail to address the underlying disease mechanisms. CABG does provide marked improvements in both patient morbidity and mortality, however, this open-heart surgical intervention is highly invasive, traumatic, expensive and has a limited lifetime. Because most CABG grafts utilize re-purposed veins, 50% become occluded within ten years after bypass surgery. PCI procedures are provided over a 24-hour hospital stay, have one-two days of recovery time and cost approximately one-fourth of CABG yet are currently administered to only 10% of CTO patients. In the most common PCI procedure, subintimal crossing, a mechanical wire is advanced past the CTO inside the vessel wall. Few interventionalists practice subintimal crossing because the procedure is difficult, risky and associated with higher MACE, restenosis, acute MI and death. Although many intravascular devices have been introduced to perform PCI true-lumen CTO crossing, all have failed in the coronary arteries. Failure of these previous devices is due to at least one of three causes: 1) large-diameter catheters that are too rigid with poor steerability; 2) non-specific injury to the vessel wall resulting from CTO cutting; and 3) absence of a navigational guidance system based on real-time imaging of the catheter tip relative to the arterial wall. An optoacoustic (OA) and ultrasound (US) image-guided cold laser wire (CLW) is proposed that provides controlled cutting that will allow any interventional cardiologist to provide patients safe and efficacious PCI true-lumen CTO crossing. Development of the transvenous OA/US image-guided CLW will be accomplished by completing three specific aims: Aim 1: Develop an Optoacoustic (OA)/Ultrasound (US) Transvenous Image-Guided Cold Laser Wire; Aim 2: Test CLW True-Lumen PCI CTO Crossing in ex vivo Human CABG Hearts; Aim 3: Test CLW True-Lumen PCI Crossing of Calcified CTOs in in vivo Animal Models. Successful completion of the proposed research and development program will introduce a true-lumen PCI CTO crossing procedure that when followed by stenting can establish a superior and new treatment paradigm for interventional cardiology and can impact other surgical disciplines.

摘要 冠状动脉慢性完全闭塞（CTO）是由硬纤维钙化物质组成的动脉粥样硬化斑块 其100%限制管腔横截面，导致受影响动脉中的血流完全停止， 至少三个月CTO症状包括呼吸急促伴慢性疲劳和胸痛。的 三种主要CTO治疗方案是药物治疗（MT）、冠状动脉旁路移植术（CABG）和 经皮冠状动脉介入治疗（PCI）。MT可以减轻胸痛等症状，但无法解决 潜在的疾病机制。冠状动脉旁路移植术确实显著改善了患者的发病率， 然而，这种心脏直视手术干预是高度侵入性的、创伤性的、昂贵的，并且具有有限的 辈子由于大多数CABG移植物利用了重新利用的静脉，50%在术后10年内发生闭塞。 心脏搭桥手术PCI手术在24小时住院期间提供，有一到两天的恢复时间 成本约为CABG的四分之一，但目前仅用于10%的CTO患者。在 最常见的PCI手术，内膜下穿过，机械导丝推进通过血管内的CTO 墙很少有介入医生实践内膜下交叉，因为该手术困难，风险大， MACE、再狭窄、急性心肌梗死和死亡率较高。尽管已经引入了许多血管内装置， 进行PCI真腔CTO通过，均在冠状动脉内失败。这些以前的失败 器械失效至少是由于以下三种原因之一：1）大直径导管太硬，可操控性差; 2)CTO切割导致的血管壁非特异性损伤;和3）缺乏导航引导 基于导管尖端相对于动脉壁的实时成像的系统。光声（OA）和 提出了超声（US）图像引导的冷激光线（CLW），其提供受控切割， 任何介入心脏病专家为患者提供安全有效的PCI真腔CTO通过。 将通过完成三项具体的 目的：目的1：开发一种光声（OA）/超声（US）经静脉图像引导冷激光器 导丝;目标2：测试CLW真腔PCI CTO通过离体人体CABG心脏;目标3：测试CLW 体内动物模型中钙化CTO的真腔PCI通过。成功完成 拟议的研发计划将引入一种真腔PCI CTO通过程序， 可为介入心脏病学建立一种上级和新的治疗范例 并可能影响其他外科学科。